When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)

And the positive news continues to flow for Revolution Medicines Inc. On the heels of a successful phase III trial for RAS inhibitor daraxonrasib in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC) – not to mention the firm pricing the largest follow-on offering in biopharma history – Revolution presented updated phase I/II data at the American Association for Cancer Research (AACR) meeting detailing impressive findings in first-line PDAC patients.

Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.

Arriving a week ahead of April 28 PDUFA date, the U.S. FDA approval of Merck & Co. Inc.’s Idvynso (doravirine/islatravir) brings a new treatment option to adults with HIV-1 infection who are virologically suppressed. The approval is for those with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.

Ever since Teva Pharmaceutical Industries Ltd. sued Eli Lilly and Co. several years ago, claiming Lilly’s migraine drug, Emgality (galcanezumab), infringed its headache treatment patents, the two companies have been on a litigation rollercoaster.

U.S. FDA drug approvals totaled 19 in March 2026, matching February and showing a solid level of regulatory activity, though slightly below the 22 approvals recorded in March 2025 and under the spike of 30 seen in March 2024.

Pulnovo Medical Ltd. secured $100 million in a financing round led by Medtronic plc for its pulmonary artery denervation system to treat pulmonary hypertension.

Novo Nordisk A/S reported top-line results from the phase III Hibiscus study of its pyruvate kinase-R activator, etavopivat, which was acquired through the 2022 buyout of Forma Therapeutics Holdings Inc. The results set up a potential competition for patients afflicted by sickle cell disease with fellow PKR activator mitapivat from Agios Pharmaceuticals Inc.